DIN ISO 11040-1-2017 Prefilled syringes - Part 1 Glass cylinders for dental local anaesthetic cartridges (ISO 11040-1 2015)《带药注射器 第1部分 齿科局部麻醉药筒用玻璃筒(ISO 11040-1-2015)》.pdf

1、July 2017 English price group 6No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.25!%h)“2692906www.din.deDIN I

2、SO 11040-1Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges (ISO 110401:2015),English translation of DIN ISO 11040-1:2017-07Vorgefllte Spritzen Teil 1: Glaszylinder fr Dentalkarpulen zur Lokalansthesie (ISO 110401:2015),Englische bersetzung von DIN ISO 11040-1:2017-0

3、7Seringues prremplies Partie 1: Tubes en verre pour cartouches dentaires danesthsie locale (ISO 110401:2015),Traduction anglaise de DIN ISO 11040-1:2017-07SupersedesDIN ISO 110401:199307www.beuth.deDocument comprises 8 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language ori

4、ginal shall be considered authoritative.07.17 A comma is used as the decimal marker. Content Page National foreword 3 National Annex NA (informative) Bibliography 3 Foreword .41 Scope .52 Normative references 53 Dimensions and designation .53.1 Dimensions . 53.2 Designation 64 Requirements 64.1 Mate

5、rial . 64.2 Performance 65 Marking 6Bibliography 8.DIN ISO 11040-1:2017-07 2 National foreword This document (ISO 11040-1:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” with the active

6、participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-03 AA “Packaging systems for loading and application of medical devices”. The DIN Standards corresponding to the In

7、ternational Standards referred to in this document are as follows: ISO 720 DIN ISO 720 ISO 4802-1 DIN ISO 4802-1 ISO 4802-2 DIN ISO 4802-2 Amendments This standard differs from DIN ISO 11040-1:1993-07 as follows: a) gas cylinders of 2,2 ml size have been included; b) requirements on performance and

8、marking have been amended; c) the standard has been editorially revised. Previous editions DIN 58358-1: 1983-06 DIN ISO 11040-1: 1993-07 National Annex NA (informative) Bibliography DIN ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification DIN ISO 4802-1, Gl

9、assware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification DIN ISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification DIN ISO

10、11040-1:2017-07 3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subj

11、ect for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IE

12、C) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be n

13、oted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifyin

14、g any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience o

15、f users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supple

16、mentary information.The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 11040-1:1992), which has been technically revised with

17、the following changes: including glass cylinders of 2,2 ml size; amending the requirements on performance and marking; editorial revision of this part of ISO 11040-1.ISO 11040 consists of the following parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local anaest

18、hetic cartridges Part 2: Plungers stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesthetic cartridges Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Part 5: Plunger stoppers for injectables Part 6: Plastics barrels for

19、injectables Part 7: Packaging systems for sterilized subassembled syringes ready for filling Part 8: Requirements and test methods for finished prefilled syringesDIN ISO 11040-1:2017-07 4 1 ScopeThis part of ISO 11040 specifies the design, dimensions, materials, performance and test methods for glas

20、s cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only.NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499.It applies to primary packs used in direct contact with a drug.NOTE 2 The potency, purity, stability and safety of a

21、 drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only th

22、e edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 720, Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classificationISO 48021, Glassware Hydrolytic resistance of the interior surfaces

23、 of glass containers Part 1: Determination by titration method and classificationISO 48022, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification3 Dimensions and designation3.1 DimensionsThe dimensions of the glass

24、 cylinder shall be as shown in Figure 1.Variations of the design of the truncated cone are allowed, if at the same time, the following conditions are fulfilled: truncated cone has the height of the neck length (5 0,2) mm; stated tolerances of the neck opening are maintained; diameter of the neck ope

25、ning at the inner end and at the cone may be a maximum of 0,3 mm smaller than the top (3,15 0,15) mm.DIN ISO 11040-1:2017-07 5 3.2 DesignationGlass cylinders for dental local anaesthetic cartridges shall be designated by a reference to this part of ISO 11040, followed by the colour of the glass.EXAM

26、PLE A glass cylinder for dental local anaesthetic cartridges (cylinder), made of clear glass (cl) tubing of hydrolytic resistance container class ISO 48021 and ISO 48022 HC 1, in accordance with this part of ISO 11040 is designated as follows:Glass cylinders for dental local anaesthetic cartridges I

27、SO 110401 cl4 Requirements4.1 MaterialThe material shall be colourless (cl) glass of hydrolytic resistance grain class ISO 720 HGA 1.A change in the chemical composition of the glass material should be notified to the user at least nine months in advance.4.2 Performance4.2.1 Glass cylinders made of

28、glass tubing should have a sealing surface at the open end of the neck which is flat and free from ripples or undulations which would affect the sealing performance.4.2.2 Glass cylinders should not contain seed or bubbles to an extent which will interfere with the visual examination of the contents.

29、4.2.3 Glass cylinders should not have open air lines on the inside surface which can lead to leakages.4.2.4 When tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the glass cylinder shall comply with the requirements of the hydrolytic resistance

30、 container class ISO 4802 HC 1.Before conducting the test, the bottom end of the cylinder shall be sealed with a suitable closure element, e.g. silicon rubber.4.2.5 If the glass cylinder is annealed, the maximum residual stress shall not produce an optical retardation exceeding 40 nm/mm of glass thi

31、ckness.The test method shall be agreed upon between the glass manufacturer and the customer.5 MarkingThe outer packaging of the glass cylinders shall be marked with the following information:a) size of the glass cylinder;b) number of cylinders it contains;c) designation of the cylinders;d) name or s

32、ymbol of the manufacturer;e) lot number (only if the cylinder is printed) or date of production.Other markings on the outer packaging are subject to agreement between the manufacturer and the customer.DIN ISO 11040-1:2017-07 6 Dimensions in millimetresKeyl length of the glass cylinder are as follows

33、:(62,4 0,4) mm for 1,7 ml/1,8 ml glass cylindersc(75,0 0,4) mm for 2,2 ml glass cylinderscaDimension 3,15 mm 0,15 mm over a depth of 5 mm 0,2 mm, but see also 3.1.bSlightly rounded.cDesignation of volume either as filled-in volume or removable volume.NOTE Any deviations are subject to agreement between the manufacturer and the customer.Figure 1 Typical glass cylinder for dental local anaesthetic cartridgesDIN ISO 11040-1:2017-07 7 Bibliography1 ISO 11499, Dentistry Single-use cartridges for local anaestheticsDIN ISO 11040-1:2017-07 8